Testosterone Cypionate Injectable Lacks Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 30mg/mL injectable due to lack of assurance of sterility. The affected lot was distributed across the United States, Washington D.C., and Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a compounded injectable drug with lack of sterility assurance. Injectable medications without assured sterility present serious infection risk and meet the Severe (score 4) threshold: significant risk of harm from non-sterile drug product.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 30mg/mL #1 in Ethyl Oleate Injectable (Rx only) due to lack of assurance of sterility. The recalled product is in 1-vial containers with Lot T0504202021:26 and a beyond-use-date (BUD) of 10/17/2021.
The product was distributed throughout the United States, including Washington D.C. and Puerto Rico.
Patients should not use this medication and should consult their healthcare provider. Healthcare providers should contact patients who may have received this product and advise them of the recall and potential risks associated with non-sterile injectable medications.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 30MG/ML #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: T0504202021:26 BUD: 10/17/2021
Distribution
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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